Vaccine Therapy With or Without Fludarabine in Treating Patients With Stage IV Kidney Cancer

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Vaccines made from a person's tumor cells and white blood cells may make the body build an immune response to kill tumor cells. Drugs used in chemotherapy, such as fludarabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining vaccine therapy with fludarabine may kill more tumor cells.

PURPOSE: This randomized phase II trial is studying vaccine therapy and fludarabine to see how well they work compared to vaccine therapy alone in treating patients with stage IV kidney cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Luke's Medical Center
• Treatments: Fludarabine; Fludarabine phosphate; Keyhole-limpet hemocyanin; Vaccines

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed renal cell carcinoma

• Stage IV disease

• Received no benefit from standard therapy OR ineligible for standard therapy OR declined standard therapy

• At least 1 site of metastatic disease that can be surgically removed AND at least 1 site of metastatic disease than can remain in the patient (indicator lesion) after surgery

• Total volume of the site or sites of disease to be surgically removed must be > 2.0 cm^3

• Unidimensionally measurable disease

• At least 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan

• No brain metastasis

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• More than 6 months

Hematopoietic

• WBC ≥ 3,000/mm^3

• Platelet count ≥ 75,000/mm^3

• Hemoglobin ≥ 10 g/dL

Hepatic

• SGPT and SGOT ≤ 2.5 times upper limit of normal (ULN)

• Bilirubin ≤ 1.5 times ULN

• Hepatitis C antibody negative

• Hepatitis B surface antigen negative

Renal

• Creatinine ≤ 1.5 times ULN

• Creatinine clearance > 40 mL/min

Cardiovascular

• No symptomatic congestive heart failure

• No unstable angina pectoris

• No cardiac arrhythmia

Immunologic

• Coomb's test negative

• HIV-1 and -2 negative

• No active infection

• No unexplained fever (temperature > 100.5° F or 38.1°C)

• No lymphocytopenia

• No hypogammaglobulinemia

• No autoimmune disease or other immunocompromising condition that would preclude study participation

• No history of impaired immune response

• No history of tuberculosis OR positive PPD skin test

• No history of allergic reaction attributed to compounds of similar biological composition to study vaccine

• No history of allergic reaction to antibiotics

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 1 month after study participation

• No psychiatric illness or social situation that would preclude study participation

• No other malignancy within the past 5 years except resected basal cell carcinoma or carcinoma in situ of the cervix

• No other concurrent illness

PRIOR CONCURRENT THERAPY:

Biologic therapy

• More than 4 weeks since prior immunotherapy

Chemotherapy

• More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)

Endocrine therapy

• At least 4 weeks since prior steroid therapy or steroid-containing compounds

• At least 2 weeks since prior topical or inhaled steroids

Radiotherapy

• More than 4 weeks since prior radiotherapy

Surgery

• See Disease Characteristics

Other

• More than 4 weeks since prior investigational agents

• More than 1 week since prior antibiotics

• No concurrent renal dialysis

• No concurrent anticoagulants

• No other concurrent anticancer agents or therapies

• No other concurrent investigational agents